Dr. Noah Biotech Completes Phase 1 Clinical Trial of Stroke Treatment NDC-002

Dr. Noah Biotech (CEO Lee Ji-hyun) announced on the 24th that it has successfully completed Phase 1 clinical trials of the complex new drug ‘NDC-002,’ which is being developed as a stroke recovery treatment, and plans to conduct a pre-IND meeting with the U.S. Food and Drug Administration (FDA) within this year to enter global Phase 2 clinical trials.

NDC-002 is Korea’s first AI-based complex new drug, developed from Dr. Noah Biotech’s proprietary ARK platform (an AI-based drug development platform). It helps stroke patients recover by reducing neuroinflammation to minimize brain damage while simultaneously promoting differentiation and recovery of brain nerve cells in the damaged brain areas.

The Phase 1 clinical trial of NDC-002, titled “an open-label, single-group, Phase 1, repeated-dose clinical trial to evaluate drug interactions, safety, and tolerability of NDC-002A/NDC-002B and NDC-002C in healthy adult volunteers,” was approved by the Ministry of Food and Drug Safety on April 18 last year. Dosing began in January this year at Insan Medical Foundation Metro Hospital, and safety follow-up visits for all subjects were completed in March.

According to the clinical trial report, statistical analysis comparing blood concentrations of individual drugs administered alone and in combination through pharmacokinetic indicators showed no significant drug interactions. Additionally, no serious adverse events (SAEs) or unexpected serious adverse drug reactions (SUSARs) occurred, and all subjects recovered without complications or sequelae.

Furthermore, there was a statistically significant difference in the incidence of adverse reactions between the combination therapy group and the monotherapy group, with the combination therapy group showing a relatively markedly lower number of adverse reactions compared to the monotherapy group. This led to the conclusion that the complex new drug NDC-002 is safer in terms of side effects than each individual drug. Based on these results, the company explained that the safety and tolerability of the combined administration of each drug constituting NDC-002 were demonstrated in this clinical trial.

A representative of Dr. Noah Biotech stated, “Based on the positive results of this Phase 1 clinical trial, we plan to conduct a pre-IND meeting with the U.S. Food and Drug Administration (FDA) within this year and proceed to global Phase 2 clinical trials.”

Meanwhile, Dr. Noah Biotech is an AI-based new drug development specialist company that has formed expert groups in AI systems, new drug development, clinical development, and business strategy internally to accelerate the development of complex new drugs for various neuromuscular rare diseases.

By implementing AI technology specialized in drug combinations, Dr. Noah Biotech aims to be the first to launch AI-developed drugs on the market. Currently, the company is preparing an FDA clinical trial application for its second pipeline, NDC-011 (a candidate drug for Lou Gehrig’s disease).

This content was produced with the assistance of AI translation services.